QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors

Male and female subjects ≥ 16 years of age with a diagnosis of EFT or DSRCT who have relapsed or progressed after at least one prior chemotherapeutic regimen will be eligible for this study.

Before any study-specific procedure, the appropriate written informed consent must be obtained.

Inclusion Criteria:

Disease Related Subjects with pathological or histological diagnosis of Ewing's Family Tumor or Desmoplastic Small Round Cell Tumor.

* Measurable disease as defined by RECIST.
* Documented failure of at least one prior chemotherapy regimen for their disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

Demographic

* Males or females ≥ 16 years old.
* Signed written informed consent.
* Able to comply with visits and procedures.

Laboratory

* Willing to provide existing and/or newly acquired tumor samples.
* Diabetic Subjects (Type 1 or 2) must have HgbA1c \< 8.0% and fasting blood glucose level \< 160 mg/dL.

General

* Must be willing and able to use birth control (double barrier protection or abstinence) during and for 6 months after the study
* Prior exposure to another anti-IGF-1R therapy will only be allowed for a limited number of additional subjects (up to 10) in an exploratory cohort

Exclusion Criteria

Disease Related

* Known brain metastasis.
* History of bleeding diathesis.
* History of another malignancy.
* History of chronic hepatitis.
* Documented prior history of human immunodeficiency virus.

Laboratory

* Absolute neutrophil count \< 1.5 x109/L.
* Platelet count \< 100 x 109/L.
* Hemoglobin \< 9 g/dL.
* PT \> 1.5 x institutional upper limit of normal (IULN) or PTT \> 1.0 x IULN.
* Serum creatinine \> 1.5 x IULN.
* Aspartate aminotransferase (AST) \> 2.5 x IULN or Alanine aminotransferase (ALT) \> 2.5 x IULN (\> 5.0 x if liver metastases present).
* Total bilirubin \> 1.5 IULN (\> 3.0 x with documented Gilbert's Syndrome)

Medication

* Antitumor treatment within 21 days of Study Day 1.
* Anticoagulation therapy within 28 days of Study Day 1.
* Major surgery within 28 days of Study Day 1.

General

* Other investigational procedures are excluded.
* Inability to tolerate intravenous administration.
* Subject is pregnant (eg, positive HCG test) or is breast feeding.